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Brief Title: Cabozantinib S-Malate in Treating Patients With Recurrent or Metastatic Endometrial Cancer
Official Title: A Phase 2 Study of XL184 (Cabozantinib) in Recurrent or Metastatic Endometrial Cancer
Study ID: NCT01935934
Brief Summary: This phase II trial studies how well cabozantinib s-malate works in treating patients with endometrial cancer that has come back (recurrent) or has spread to other places in the body (metastatic). Cabozantinib s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Detailed Description: PRIMARY OBJECTIVES: I. Determine efficacy of single agent cabozantinib s-malate (cabozantinib) in women previously receiving one line of chemotherapy for metastatic endometrial cancer or with progression within 12 months of completing adjuvant therapy, with co-primary endpoints of objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and progression-free-survival at 12 weeks (PFS). SECONDARY OBJECTIVES: I. Correlation of clinical response with baseline molecular status of archival tumor (hepatocyte growth factor receptor \[c-met\] amplification \& mutation status) and overall survival. OUTLINE: Patients receive cabozantinib s-malate orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 4 weeks or every 6 months.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
City of Hope Comprehensive Cancer Center, Duarte, California, United States
Los Angeles General Medical Center, Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
City of Hope South Pasadena, South Pasadena, California, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Decatur Memorial Hospital, Decatur, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital, Evanston, Illinois, United States
Southern Illinois University School of Medicine, Springfield, Illinois, United States
Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
UPMC-Magee Womens Hospital, Pittsburgh, Pennsylvania, United States
Tom Baker Cancer Centre, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada
Kingston Health Sciences Centre, Kingston, Ontario, Canada
London Regional Cancer Program, London, Ontario, Canada
Ottawa Hospital and Cancer Center-General Campus, Ottawa, Ontario, Canada
University Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada
Name: Neesha Dhani
Affiliation: University Health Network-Princess Margaret Hospital
Role: PRINCIPAL_INVESTIGATOR